U.S. patent application number 13/134253 was filed with the patent office on 2011-12-08 for surgical device with smart bit recognition collet assembly to set a desired application mode.
This patent application is currently assigned to Biomet Microfixation, LLC. Invention is credited to Christopher C. Dyer, Saddy R. Garcia, Benjamin J. Gray, Ryan Nicholas Luby, Allan J. Meredith, Larry Miller, Bradley Winterroth.
Application Number | 20110301611 13/134253 |
Document ID | / |
Family ID | 44515157 |
Filed Date | 2011-12-08 |
United States Patent
Application |
20110301611 |
Kind Code |
A1 |
Garcia; Saddy R. ; et
al. |
December 8, 2011 |
Surgical device with smart bit recognition collet assembly to set a
desired application mode
Abstract
A surgical device of a drill/driver with bit recognition to set
a desired application mode and a method of utilization thereof is
provided. Various operating modes of the drill/driver are
automatically set by a sensor which recognizes the bit applied to
the drill/driver. A method of utilizing the drill/driver allows the
drill driver to apply surgical screws at very high speeds while
automatically preventing excessive torque levels that would strip
out the surgical screw from the patient's bone.
Inventors: |
Garcia; Saddy R.; (Saint
Augustine, FL) ; Winterroth; Bradley; (Wesley Chapel,
FL) ; Luby; Ryan Nicholas; (Atlantic Beach, FL)
; Miller; Larry; (Ponte Vedra Beach, FL) ; Dyer;
Christopher C.; (Overland Park, KS) ; Gray; Benjamin
J.; (Kansas City, MO) ; Meredith; Allan J.;
(Overland Park, KS) |
Assignee: |
Biomet Microfixation, LLC
Jacksonville
FL
|
Family ID: |
44515157 |
Appl. No.: |
13/134253 |
Filed: |
June 2, 2011 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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61396803 |
Jun 3, 2010 |
|
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Current U.S.
Class: |
606/80 ;
606/104 |
Current CPC
Class: |
B25B 21/002 20130101;
A61B 17/8625 20130101; A61B 17/162 20130101; A61B 2090/031
20160201; B25B 21/00 20130101; A61B 2090/066 20160201; A61B 17/1617
20130101; A61B 17/1626 20130101; A61B 90/90 20160201; A61B 90/98
20160201; B25B 23/147 20130101; A61B 17/8875 20130101; B25B 23/0035
20130101; B25B 23/14 20130101; A61B 17/16 20130101; A61B 90/03
20160201 |
Class at
Publication: |
606/80 ;
606/104 |
International
Class: |
A61B 17/16 20060101
A61B017/16; A61B 17/56 20060101 A61B017/56 |
Claims
1. A multiple use surgical drill/driver and bit system comprising:
a surgical drill/driver including a connector for connecting a
plurality of bits; a plurality of bits, each bit having a unique
identifier; a sensor connected on said surgical drill/driver for
identifying said bit connected with said surgical drill/driver; a
memory defining an operational parameter for said identified bit
specific to said identified bit; a manual controller responsive to
a manual command signal to operate said surgical drill/driver; and
an override controller overriding said manual command signal to
said surgical drill/driver when said manual command signal is
outside a desired operational parameter for said identified
bit.
2. A surgical drill/driver and bit system as described in claim 1
wherein said operational parameter is rotational speed and
derivatives thereof.
3. A surgical drill/driver and bit system as described in claim 1
wherein said operational parameter is output torque level and
derivatives thereof.
4. A surgical drill/driver and bit system as described in claim 3
wherein said operational parameter is an output torque level
acceleration, and wherein said override controller determines a
thread insertion stage of operation as being prior to the first
spike in output torque level acceleration, a surgical screw head to
plate contact stage of operation subsequent to said first spike in
output torque acceleration and prior to a second spike in output
torque acceleration, and a compression stage of operation
subsequent to said second spike in output torque acceleration.
5. A surgical drill/driver and bit system as described in claim 4
wherein said surgical drill/driver override controller cuts off
operation of said surgical drill/driver to prevent strip out after
said second spike in torque acceleration.
6. A surgical drill/driver and bit system as described in claim 3
wherein said operational parameter is torque level and wherein said
override controller determines a first peak in output torque level,
a first valley in output torque level subsequent to said first peak
in output torque level, and a negative first derivative in output
torque level subsequent to said first valley in output torque level
wherein said override controller shuts off said surgical
drill/driver to prevent strip out of a surgical screw from a
patient's bone matter.
7. A surgical drill/driver and bit system as described in claim 6
wherein said torque level is determined by motor current.
8. A surgical drill/driver and bit system as described in claim 1
wherein said surgical drill/driver override controller has a time
limiter to prevent overheating of said surgical drill/driver.
9. A surgical drill/driver and bit system as described in claim 8
wherein said time limiter is overridden by said surgical
drill/driver override controller if said surgical drill/driver is
experiencing a minimum torque level as an indicator of insertion of
said bit within a bone of a patient.
10. A surgical drill/driver and bit system as described in claim 1
wherein said identifier is a length of a portion of said bit.
11. A surgical drill/driver and bit system as described in claim 10
further including a plunger loaded against said connected bit to
aid in determination in said bit length.
12. A surgical drill/driver and bit system as described in claim 11
having a collet type connector.
13. A surgical drill/driver and bit system as described in claim 12
wherein said drill/driver has a rotating tubular shaft and wherein
said plunger is positioned within said tubular shaft, said tubular
shaft having opposing hooked stops for locking receipt of wings of
said bit.
14. A surgical drill/driver and bit system as described in claim 13
wherein said collett has stops contacting said bit wings to lock
said bits from rotation with respect to said tubular shaft.
15. A surgical drill/driver and bit system as described in claim 14
wherein said collet has a window and wherein said window determines
an angular orientation of receipt of said wings of said bit.
16. A surgical drill/driver and bit system as described in claim 13
wherein said bit has a working end, opposing radially extending
wings, and an identifier end portion for insertion within said
shaft for contact with said plunger to set an axial position of
said plunger.
17. A surgical drill/driver including: a body mounting a motorized
shaft with a connected driver bit for driving a surgical screw; and
a controller cognizant of a torque level output of said
drill/driver, wherein said controller determines a thread insertion
stage of operation as being prior to a first spike in output torque
acceleration, a surgical screw head to object contact stage of
operation subsequent to said first spike in output torque level
acceleration and prior to a second spike in output torque
acceleration and a compression stage of operation subsequent to
said second spike in output torque acceleration wherein said
controller shuts off surgical drill/driver to prevent strip out
after said second spike in output torque level acceleration.
18. A surgical drill/driver including: a body mounting a motorized
shaft with a connected driver bit for driving a surgical screw; and
a controller cognizant of a torque level output of said
drill/driver, wherein said controller determines a first peak in
output torque level, a first valley in output torque level
subsequent to said first peak in output torque level, and a
negative first derivative in output torque level subsequent to said
first valley in output torque level wherein said controller shuts
off said surgical drill/driver to prevent strip out of a surgical
screw from a patient's bone matter.
19. A method of securing a threaded fastener to a patient's body
comprising: torquing said fastener with a surgical drill/driver;
monitoring the output torque level utilized by said surgical
drill/driver; determining a peak of acceleration of an output
torque level of said surgical drill/driver; and controlling a
torque output of said surgical drill/driver in response to said
torque level output acceleration peak.
20. A method of securing a threaded fastener to a patient's body as
described in claim 19 further comprising controlling said surgical
drill/driver in response to said output torque acceleration peak
irrespective of a manual command signal to said surgical
drill/driver.
21. A method of securing a threaded fastener to a patient's body as
described in claim 19 comprising cutting off said surgical
drill/driver in response to said peak of acceleration of the output
torque level of said surgical drill/driver.
22. A method of securing a threaded fastener to a patient's body as
described in claim 21 further comprising turning off said surgical
drill/driver upon a second peak of acceleration of the output
torque level of said surgical drill/driver.
23. A method as described in claim 22 further comprising detecting
a head of said threaded fastener making contact with said object in
response to a peak in output torque level acceleration.
24. A method of securing a threaded fastener to a patient's body as
described in claim 19 further comprising attaching an object to
said patient's body with said threaded fastener.
25. A method of securing a threaded fastener to a patient's body as
described in claim 24 further comprising turning off said surgical
drill/driver upon a second peak of acceleration of the output
torque level of said surgical drill/driver.
26. A method as described in claim 20 further comprising detecting
a compression stage of operation of said surgical drill/driver by a
second peak of output torque accelerator.
27. A method of securing a threaded fastener to a patient's body
comprising: torquing said fastener with a surgical drill/driver;
monitoring the output torque level utilized by said surgical
drill/driver; determining a first peak in torque level; determining
a valley in torque level after said first peak; determining that a
first derivative of torque level with respect to time has gone
negative after said first valley to shut off said drill/driver.
28. A method as described in claim 27 wherein said monitoring of
said torque level is determining by monitoring a current level of a
motor powering said drill/driver.
29. A method as described in claim 27 when utilizing a self-tapping
surgical screw.
30. A method as described in claim 27, when utilizing a self
drilling surgical screw.
31. A surgical drill/driver and bit system as described in claim 12
wherein to release said connected bit said collett is pulled
forward.
32. A surgical drill/driver and bit system as described in claim 10
wherein said bit connected with said connector comprises: a working
end; opposing radially extending wings; and an identifier end
portion.
33. A surgical bit system having a plurality of generally
cylindrical bits, each bit having a unique identifier, each bit
comprising: a distal working end portion; a proximal identifier end
portion; and at least one radially extending wing intermediate the
working end portion and the identifier end portion; the length of
the identifier end portion extending from the at least one wing to
the proximal most end of the identifier end portion uniquely
identifying the bit within the plurality of bits.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/396,803, filed Jun. 3, 2010.
FIELD OF THE INVENTION
[0002] The present invention relates to methods of securing a
threaded fastener into a patient's body and to a surgical
drill/driver utilized for inserting and torquing a surgical screw
into a patient's body.
BACKGROUND OF THE INVENTION
[0003] Surgical screws are utilized for various purposes in
surgical operations. Surgical screws are utilized for repairing
fractures in bones or for attaching a prosthesis to a bone.
Surgical screws are also utilized for plates connected with a
patient's body either permanently or temporarily after an
operation. When using a surgical drill/driver in an operating
environment, it is desirable that the drill/driver torque the screw
within the patient's body in the safest, most efficient manner
possible.
[0004] In many facial or cranial operations, a plate is utilized to
stabilize two sections of bone after completion of the operation.
Prior to the present invention, typically a hole was drilled into
the patient's bone with a surgical drill/driver. A self-tapping
suigical screw was then torqued into the hole by hand by the
surgeon. In an alternate method, a self drilling surgical screw was
utilized. The surgeon, buy virtue of their experience and tactile
touch, was careful not to over torque the surgical screw. Over
torquing the surgical screw could thereby cause a strip out of the
threads that were created within the patient's bone mass.
[0005] Although hand torquing threaded surgical screws to attach a
plate to a patient's bone is efficient, there are certain
undesirable conditions that can occur. Hand torquing a surgical
screw can provide a less than optimal result due to the inherent
wobble in the rotational axis of a screw driver when the screw
driver is turned manually. Even in the hands of the most skilled
surgeon, some wobble typically occurs. Secondly, strip out of the
threads formed in the bone by over torquing the surgical screw is
primarily dependent upon the skill of the surgeon. Thirdly, it is
desirable to torque the surgical screw and associated plate to the
patient's body in a method that additionally requires less effort
by the surgeon. Fourthly, it is desirable to complete torquing of
the surgical screw to the patient in less time than a manual
torquing procedure.
[0006] To improve upon the manual operation of torquing a surgical
screw into a patient's bone to secure a plate to patient's body,
various powered surgical drills/drivers have been developed. Most
of the surgical drill/drivers are electrically and preferably
battery powered. One of the major advantages of the electrically
powered drill/driver is that the axis of torque remains constant
during the torquing operation and therefore the wobble inherent in
manual operation by the surgeon is eliminated. However, with the
mechanized torquing of the surgical screw into the patient's bone,
there is a lack of tactile feedback to the surgeon to alert the
surgeon that further torquing operation can inadvertently cause a
strip out of the threads formed within the bone matter of the
patient.
[0007] Prior manual bone screw insertion techniques typically
require three to five seconds. To reduce the time required, there
has been trend to go toward aforementioned mechanical
drill/drivers. However, increasing the speed on a mechanical
drill/driver increases the chances of an inadvertent strip out of
the formed threads in the patient's bone matter. It is desirable to
provide a drill/driver and a method of utilizing the same wherein
strip out of the threads formed in the patient's bone can be
prevented while allowing the drill/driver to operate to connect a
surgical screw with a patient within time segments as short as 45
ms (actual screw insertion time varies dependent upon the size of
the screw). Additionally, it is also desirable to provide a
drill/driver that has a form of bit recognition to allow the
surgical drill/driver to override a manual command signal to the
drill/driver when the manually commanded signal of the drill/driver
is outside a desired operational parameter for the drill bit or
driver bit that is connected with the surgical drill/driver.
SUMMARY OF THE INVENTION
[0008] To make manifest the above noted and other manifold desires,
a revelation of the present invention is brought forth. In a
preferred embodiment, the present invention provides a surgical
drill/driver wherein various operating modes of the drill/driver
are automatically set by a controller that recognizes a bit applied
to the drill/driver. Additionally, a preferred embodiment of the
present invention provides a method of utilizing the above noted
drill/driver that allows the drill/driver to apply surgical screws
at very high speeds while automatically preventing excessive torque
levels that can strip out the surgical screw from the patient's
bone matter.
[0009] Other advantages of the present invention will become more
apparent to those skilled in the art from a review of the invention
as it is provided in the accompanying drawings and detailed
description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The present invention will become more fully understood from
the detailed description and the accompanying drawings,
wherein:
[0011] FIG. 1 is a perspective view of a surgical drill/driver
according to the present invention;
[0012] FIG. 2 is a perspective sectional view of the drill/driver
shown in FIG. 1;
[0013] FIG. 3 is a perspective view of various drill and driver
bits utilized with the drill/driver shown in FIGS. 1 and 2;
[0014] FIG. 4 is an enlarged perspective view of an alternative
arrangement collett for the drill/driver according to the present
invention;
[0015] FIG. 5 is a rear perspective view of a front portion of a
collett shown in FIG. 4;
[0016] FIG. 6 is another rear perspective view of the front portion
of a collett shown in FIG. 4;
[0017] FIG. 7 is a front view of the front portion of the collett
shown in FIG. 4;
[0018] FIG. 8 is a side elevation view of the front portion of the
collett shown in FIG. 4;
[0019] FIG. 9 is a perspective view of a rear portion of the
collett shown in FIG. 4;
[0020] FIG. 10 is a side elevation view of the rear portion of the
collett shown in FIG. 4;
[0021] FIG. 11 is an enlarged perspective view of a front portion
of a tubular shaft utilized with the collett of FIG. 4;
[0022] FIG. 12A is a side elevation view of a drill bit utilized
with the collett shown in FIG. 4;
[0023] FIG. 12B is a top elevation view of a drill bit utilized
with the collett shown in FIG. 4;
[0024] FIG. 12C is an enlarged perspective view of a portion of the
drill bit shown in FIG. 12A;
[0025] FIG. 13 is a side elevation view of a fastener driver
utilized with the collett of FIG. 4 for metallic surgical
screws;
[0026] FIG. 14 is a driver for lactosorbic bits utilizing the
collett of FIG. 4;
[0027] FIG. 15 is a front view of the collett shown in FIG. 4
illustrating a bit being installed within the collett;
[0028] FIG. 16 is a graphic representation of a method utilizing
the drill/driver according to the present invention illustrating
the relationship between torque level and time;
[0029] FIG. 17 is a graphic representation of the method of
illustrating the relationship of torque level acceleration and time
of the method represented in FIG. 16;
[0030] FIG. 18 is a view similar to that of FIG. 16 illustrating
the aforementioned method of utilizing a larger surgical screw than
that utilized in the generation of the relationship illustrated in
FIG. 3;
[0031] FIG. 19 is a graphic representation similar to that of FIG.
17 illustrating the relationship between torque level acceleration
and time of the method represented in FIG. 18;
[0032] FIG. 20 is a view similar to that of FIG. 16 which
additionally shows the relationship between torque level and time
for multiple densities of bone;
[0033] FIG. 21 is a graphical representation similar to that of
FIG. 17 illustrating the relationship between torque level
acceleration and time of the methods represented in FIG. 20;
[0034] FIG. 22 is a graphical representation of another preferred
embodiment method utilizing the drill/driver according to the
present invention.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] The following description of the preferred embodiment(s) is
merely exemplary in nature and is in no way intended to limit the
invention, its application, or uses.
[0036] Referring to FIGS. 1, 2 and 3, a multiple use surgical
drill/driver assembly 7 with a smart bit recognition system is
provided. The surgical drill/driver 7 has a drill body 10. The
drill body 10 is typically fabricated from a metal or polymeric
material. The drill body 10 in its rearward end is connected with a
battery pack 14 to allow the surgical drill/driver 7 to function
without a power cord.
[0037] The drill body 10 mounts a brushless motor 11. The motor 11
typically has a nominal 20 watt output with a stall torque of 195 m
Nm and has a variable (no load) speed to 35,500 rpm. A large
portion of the control electronics are located on a circuit board
23 located under the motor 11. The drill body 10 has a handle 22.
An overhead manual control trigger 24 is responsive to an input of
the surgeon. The trigger 24 provides a manual command signal to the
motor 11.
[0038] The motor 11 drives an outer shaft 25. The outer shaft
drives an inner shaft 26. At an extreme end of the inner shaft 26
is a collet connecter 28. A forward push on the collet 28 positions
an enlarged portion 30 of a collet multiple inner diameter 32 to be
adjacent to a retainer bearing ball 34 allowing the retainer ball
to be pushed outwardly of its retainer aperture 36 in the inner
shaft 26. Selectively connected with the collet 28 is a plurality
of bits 42 and 44. The bit 42 is for a screw driver blade. The bit
44 is for a drill. The bit 44 is for a specific set of a titanium
screw. Not shown are other bits that would be for other size screws
or bio-absorbable screws. Typically the bit 42 functions for
several sizes of titanium screws of various lengths and diameters.
Each bit has a shank portion with a unique length that is measured
from a flange 47 to the shank extreme end. The shank portion 43 for
the bit 42 can have a length "A" of approximately 0.445 inches. The
portion of the shank from the flange to an annular groove 45 that
mates with the retaining bearing ball 34 is typically constant for
all of the bits. Shank 54 provided for the drill bit 44 can have a
length of approximately 0.563 inches. As explained later, the shank
lengths are used to identify to a controller of the drill/driver 7
what bit is connected with the collet 28.
[0039] Slidably mounted within the inner shaft 26 is a plunger 62.
The plunger 62 is spring loaded to make abutting contact with the
shank of a bit connected with the collet Through a slot (not shown)
in the outer shaft 25, a set of reflector targets 66 are connected
with the plunger 62. A positional sensor (or sensors) located on a
bottom of a printed circuit board 65 underneath the trigger 24
determines an axial location of the plunger 62 by determining the
position of targets 66. As mentioned previously, each bit has a
portion with a unique length as an identifying characteristic. In
an alternative embodiment (not shown) the identifying
characteristic of the various bits can be electrical resistance,
shank geometry or shape magnetic field strength of the shank, or
radio frequency identification optical characteristics or often
identifying characteristics. Desirable ranges of various
operational parameter(s) specific to the identified bit are stored
in a memory. The memory can communicate with a controller
(typically located on a circuit board 23)
[0040] When a bit is connected with the drill/driver, predetermined
desired operational parameters such as speed, torque levels,
insertion rates and/or derivatives thereof, are alerted from the
memory to the controller to control the operation of the
drill/driver 7. A rotational speed sensor informs the controller of
rotational speed data. Additionally other sensors may provide the
controller with other operational parameter realized data. In
certain conditions, the controller provides an override function.
If the surgeon attempts to operate the drill or driver outside of
the predetermined operation parameters for a given bit, the
controller provides an override function to override the manual
command signal provided by the surgeon. For example, when the
drill/driver 7 is in the drill mode, the drill/driver 7 can be
provided with a timed automatic shut off (to prevent overheating of
the motor 11). The turn off of the drill/driver 7 to prevent
overheating is also programmed to be disabled whenever the
controller determines that there is a torque level greater than 0
inch-ounces that informs the controller that the drill bit 44 is
currently within bone material and therefore shutting off of the
drill/driver 7 should not be allowed to prevent a drill bit 44
being stuck within a patients' bone matter.
[0041] Referring to FIGS. 4-15, an alternate embodiment collett and
drill bit arrangement for the present invention is provided.
Collett 70 has a front piece 72 and a rear closing end piece 74.
The front piece 72 has a generally oblong window 76. An interior of
the front piece 72 has a generally circular bore 78 with two
chordal flats 80. Extending generally radially from a portion of
the chordal flats 80 are two triangular stops 82. Rearward of the
circular bore 78 is a spring chamber 84. The collett front piece
has a rearward end 86. The collett rearward member 74 has an
annular portion 75 which is fitted within the spring chamber 84 of
the forward piece 72.
[0042] Powered by the motor 11 is a generally tubular shaft 88. The
tubular shaft 88 has a central bore 90. Slidably axially mounted
within the tubular bore 90 is a plunger 92. Connected on the front
end of the tubular shaft 88 are two opposed hook stops 94. Each
hook stop 94 has a nest 96 and an overlapping cantilever portion
98. Additionally, the tubular shaft 88 has two chordal flats 100
which are mated with the chordal flats 80 of the collett front
piece to angularly retain the collett 70 with the shaft 88. The
shaft 88 additionally has a C-ring groove 102 for installation of a
C-ring (not shown) that retains a spring (not shown) that pushes
against the C-ring. The spring additionally pushes against a
generally annular flat 77 of the collett rearward portion 74 to
bias the collett 70 rearward towards a remainder of the
drill/driver.
[0043] Referring to FIGS. 12A, 12B and 12C, a drill bit 110 is
shown with a distal working end 112 providing a drilling portion.
The drill bit additionally has opposite radially projecting wings
114 having flats 116. The bit 110 has an identifier end portion 115
of a unique length 118 from a front of the intermediate wing 114 to
its proximal end 120. End 120, upon installation with the
drill/driver, abuts the plunger 92 as the identifier end 115 is
installed within the bore 90 of the shaft 88. The length 118 is
identified by afore described drill/driver sensor system informing
the controller that a bit 110 is connected.
[0044] A metallic surgical screw driver bit 126 is provided having
a torsional screw driver head 105. Bit 126 also has wings 114 with
associated flats 116 and has a unique length 130 from the wings 114
to its end 128.
[0045] Another bit which can be utilized with the drill/driver 7 of
the present invention is a lactosorbic driver bit 140. The
lactosorbic driver bit 140 is utilized for driving a lactosorb
surgical screw and again has wings 114 with a unique length 142
from the forward end of the wing 114 to bit end 144. Typically when
using a lactosorbic bit the drill/driver 7 can have a time limiter
that will turn off the drill/driver in exceptional cases wherein
the lactosorbic screw does not shear as designed to keep the
drill/driver 7 from burning up or otherwise malfunctioning. A more
detailed review of the use of lactosorbic screws can be found by a
review of Garcia et al., U.S. Patent Publication No. 2008/0215060
A1.
[0046] To connect one of the bits with the collett, the collett 70
is pulled forward against the force of the biasing spring (not
shown). The end of a bit, for example, bit 110 with identifier end
portion 115, is inserted within the collett window 76 with an
angular orientation of the wings 114 such that the wings are
generally aligned with the window 76. The bit end 120 contacts the
plunger 92 and pushes the plunger back until the wings 114 contact
a generally annular flat 150 of the shaft. The bit 110 is torqued
bringing the wings 114 into their generally locked position within
nest 96 of the stops 94 and are captured underneath the portion 98
of the stop. Upon release of the collett 70, the spring pushes the
collett 70 rearward causing the triangular stops 82 to be
positioned in contact with the wings 114 on an opposite side of the
wings 114 from the nest 96 of the shaft, therefore locking the
wings 114 of the bit 110 in both angular directions. The bit 110 is
now ready for use. To change the bit 110, a surgeon need only to
pull forward on the collett 70 and rotate the bit 110 bringing the
bit's wings 114 out from their locked position underneath the stops
94 of the shaft and aligning the wings 114 with the window 76 of
the collett for release.
[0047] Referring to FIGS. 16-21, a method of utilizing the surgical
drill/driver 7 according to the present invention is provided. FIG.
16 is a graphic representation of torque level versus time. FIG. 17
is a graphic representation of the torque level acceleration versus
time of the surgical drill/driver utilized in FIG. 16. FIG. 18
displays the torque level verses time characteristics of the same
type of surgical screw utilizing the same driver that is utilized
in FIG. 16. However in FIG. 18 the screw has an enlarged diameter
and or enlarged length as compared with the screw utilized in FIG.
16. FIG. 19 is a graphic representation of the torque level
acceleration versus time of the surgical drill driver utilized in
FIG. 18. The middle line of FIG. 20 is a graphic representation of
torque level versus time for the same screw and same bit utilized
in developing the graphic representation of FIG. 16. Additionally
in FIG. 20, graphic representations are given for torque level
versus time when a patient has a higher or lower bone density than
normal. FIG. 21 is a graphic representation of torque level
acceleration versus time of the surgical drill/driver utilized in
FIG. 20.
[0048] Referring to FIG. 16, the surgical drill/driver according to
the present invention has approximately three stages of operation.
The first stage of operation is initial thread insertion labeled
200 in FIG. 16. The second stage of operation is of that when a
head of the surgical screw first contacts a plate. The second stage
of operation is labeled 202. The third stage of operation of the
surgical drill/driver labeled 204 is that of compression of the
bone of the patient wherein the plate is being pressed against the
patients' bone. Prior to the present invention, when manually
torquing surgical screws to a patient by virtue of the tactile
touch, the surgeon would realize when there was an increase of
torque and hold up before there was strip out of the bone material.
As mentioned previously, this manual method could possibly take
five seconds or more of operation by the surgeon. With the
drill/driver 7 according to the present invention, this process
takes approximately 0.045 to 0.060 seconds (dependent upon screw
size and patient bone density). More details on the fast screw
insertion can be gained by a review of the aforementioned Garcia et
al., U.S. Patent Publication. With the increased speeds of the
drill/driver 7 (5000 RPM to 18,000 RPM), there is not enough time
to manually turn off the drill/driver 7 to prevent an excessive
torque level 206 that would cause strip out. Strip out torque
levels 206 (FIG. 16) are not only dependent upon the size of the
surgical screw utilized, but are also dependent upon the thickness
and density of the patient's bone matter.
[0049] The graphic representation in FIG. 16 is that typically of a
titanium surgical screw of 1.5 mm diameter and 4 mm or 5 mm in
length. An example of such a screw is a 91-6104 and 91-6105 screw
manufactured by Biomet. As mentioned previously, section 200
represents initial thread insertion. At the end of initial thread
insertion (time t.sub.1), torque level is at TL1.
[0050] Referring to FIG. 17, there is a graph of torque level
acceleration versus time in seconds. At the intersection between
the thread insertion 200 and initial contact of the screw head with
plate 202, there is an intersection 210. At intersection 210 and
time "t.sub.1", there is an initial peak 213 of torque level
acceleration that is sensed and signaled to the controller of the
drill/driver 7. After the surgical screw head hits the plate, the
acceleration of torque level goes down although the actual torque
level is increasing until the screw head and plate (bottom out)
against the patient's body at intersection 214 (FIG. 16) causing a
second peaking in torque level acceleration referred to as item 215
in FIG. 17. Peak 215 occurs at torque level TL2 at time t.sub.2. At
the second spike in output torque acceleration, the controller
shuts off the surgical drill/driver 7 to prevent bone strip out.
This causes the torque output to go to zero at time t3 along a path
shown by line 220 rather than proceeding along portion 222 that
would cause strip out at position 206. Position 206 is typically
above 12-16 inch-ounces.
[0051] Referring to FIGS. 18 and 19, the graphical representation
of torque level and torque level acceleration are provided for the
same drill/driver 7 utilizing the same driver bit with the
exception of a larger diameter screw and/or longer length screw.
2.0 mm.times.7.0 mm or 2.4 mm.times.16 mm. During the initial stage
of thread insertion 300, since the surgical screw utilized in FIG.
18 is longer and or has a greater diameter than that shown in FIG.
16, both of these contribute to the time t.sub.1* (for the initial
insertion stage 300) being greater than the time t.sub.1. The first
spike in acceleration noted as 313 occurs at t.sub.1*. In the screw
head to plate contact stage of operation 302 that is subsequent to
the first spike 313 in torque level acceleration, the surgical
screw head makes contact with the plate. At point 314 and at time
t.sub.2* there is a second spike 315 in the torque level
acceleration that in the controller is cognizant of. Subsequent to
the second spike 315 of torque acceleration, the drill/driver 7
enters into a compressive stage of operation noted as 304. At the
aforementioned second spike 315 (time t.sub.2.sup.*) of torque
acceleration, the controller 65 shuts off operation of the
drill/driver 7 causing torque levels to crash along line 320
preventing the bone mass strip out. It is significant to note that
the torque level TL2* is are typically greater than TL2 due to the
increased demands for torque level output due to the increased
diameter and/or length of the surgical screw used in the operation
in FIGS. 18 and 19.
[0052] Referring to FIGS. 20 and 21, the torque level versus time
and torque level acceleration verses time graphic charts are given
for using the surgical drill/driver 7 with the same driver bit as
utilized in FIGS. 16 and 17 as provided. Also in FIGS. 20 and 21,
the same size surgical screw is being utilized. In FIG. 20, the
middle line is identical to that of FIG. 16 and represents the
surgical screw being applied to a patient with a bone having medium
density. The upper line is for the surgical screw being applied to
a patient with a bone mass with a higher density. The lower line is
for the surgical screw being applied to a patient with a damaged,
thinner or lower bone density and/or bone mass. In the case of high
density bone, the time t.sub.1** required for thread insertion 400
is greater than that of t.sub.1. Accordingly, the absolute torque
level TL1** is greater than that of TL1 and additionally the torque
level TL2** of the drill/driver 7 shut off is higher than the
torque level TL2 in the medium density bone mass. In case of lower
bone density, the time t.sub.1*** required for thread insertion 500
is less than that of t.sub.1. Accordingly, the absolute torque
level TL1*** is less than that of TL1 and additionally the torque
level TL2*** of drill/driver shut off is lower than the torque
level TL2 at shut off in the stronger medium density bone mass.
Accordingly, by utilizing the detected second spike in torsional
acceleration to control shut off of, the drill/driver 7 of the
present invention can operate in very short time spans at very high
speeds. The drill/driver 7 automatically adjusts shut off to
prevent bone strip out for the same bit, regardless of the screw
dimension or bone condition.
[0053] When utilizing the drill/driver 7 of the present invention,
the battery is first placed inside of the drill/driver. An LED
(light emitting diode) button turns on to indicate to the surgeon
that power is flowing to the drill/driver 7. The collet 28 (or 70)
is pulled forward to load a desired bit or drill into the same. If
the drill/driver 7 is utilized for driving a screw, a screw is
loaded to the driver from a tray (not shown). A plate (not shown)
is placed against the patient's bone and the tip of the screw is
contacted against the patient's bone through a hole in the plate.
The drill/driver 7 is configured so that a pressure force must be
applied against the screw by the drill/driver 7 of approximately
two pounds or the trigger 24 is inoperative to start the
drill/driver 7. The two pounds of force are required so that the
screw propels forward during the insertion state. It should be
noted that in the drilling mode, a pressure force upon the
patient's body by drill/driver 7 is not required. When the trigger
24 is fired (in the driving mode), the control system (typically
located on a circuit board within the drill/driver) begins to look
for torque changes and executes tasks as commanded as previously
explained. Upon completion of insertion of the screw, the drill/
driver 7 is removed and the next screw is loaded to the
drill/driver and the task is repeated.
[0054] FIG. 22 is a graphic representation of a method of
utilization of the drill/driver 7 of the current invention that
illustrates the relationship between torque level and time. At time
equals zero (0), the drill driver 7 as mentioned previously, is
preloaded against the patient's bone matter to allow for the
trigger 24 to be responsive to the surgeon's activation. At point
601 there is an immediate rise in current (torque level) as the
motor 11 starts to rotate. This torsional force peaks at position
602 as the screw starts an initial turning. At point 603 as torque
begins to diminish the controller recognizes that there has been a
first peak of torque level. As the motor continually picks up speed
and before the tip of the screw bites into the bone matter, there
is an initial slide in torque level noted as portion 604. As the
self drilling surgical screw initially bites into the bone matter,
there is a short stage of virtually constant torque level noted in
portion 605 of the graphic representation of FIG. 22. After initial
grabbing into the bone by the tip of the surgical screw, there is a
subsequent initial stripping out the bone matter along the inner
diameter of the surgical screw. This strip out is not the strip out
of the tap threads into the bone matter as when the screw is fully
fastened to the patient's bone matter, but is the strip out which
occurs at the very tip of the screw. This phenomenon causes a
slight lowering of the torque level that is shown graphically in
portion 606 of the graphic representation of FIG. 22. After the
initial strip out of the bone matter caused by the tip of the
threaded fastener, there is a constant rise in torque level as the
screw penetrates the bone matter of the patient. At point 607,
there is a recognition that this rise has occurred to a point that
a valley in torque level has occurred as compared with portions
604, 605 and 606 of the torque level graphic representation. At
this point, the controller is cognizant that the threaded fastener
is penetrating into the patient's bone and also tapping the
appropriate threaded path within the patient's bone. The above
noted process continues along section 608 and thereafter peak at
point 610. At point 610, the first derivative of torque level turns
negative as the fastener approaches a strip out condition in the
patient's bone matter wherein after the controller cuts off current
to the motor 11 to prevent strip out from occurring. It is apparent
to those skilled in the art that a graph similar to that as shown
in FIG. 22 will be slightly above the graph of FIG. 22 or below the
graph of FIG. 22 depending upon different conditions of bone
density as previously described in relationship with the graph of
FIG. 20.
[0055] The description of the invention is merely exemplary in
nature and, thus, variations that do not depart from the gist of
the invention are intended to be within the scope of the invention.
Such variations are not to be regarded as a departure from the
spirit and scope of the invention.
* * * * *